The STOP-HPV Trial 3: Prompts Intervention (STOP-HPV)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03599583|
Recruitment Status : Suspended (Temporarily suspending due to the impact of COVID-19 on practices.)
First Posted : July 26, 2018
Last Update Posted : May 1, 2020
|Condition or disease||Intervention/treatment||Phase|
|Immunization Vaccination||Behavioral: STOP-HPV prompts intervention||Not Applicable|
This intervention will incorporate prompts via electronic health record (EHR) (e.g. alerts in electronic charts indicating patient is due for vaccination) and study practice staff prompts (reminders from study staff that a patient is due for vaccination, e.g. placing Vaccine Information Statements (VISs) on desk) to study practitioners that encourage HPV vaccination at all visits. An initial learning module on practitioner prompts will highlight how study practices can consistently implement both EHR and staff HPV vaccination prompts at all visits. Throughout the intervention, text message mini-lessons will remind participants how to best use prompts via EHR and/or office staff to improve HPV vaccination rates. This trial focuses on study period 3 where study periods are as follows:
Period 1: Arm-1 intervention study practices receive communication skills training; Arm-2 comparison study practices provide standard of care. Period 2: Arm-1 intervention study practices add performance feedback, building upon their prior training in communication skills; Arm-2 comparison study practices continue delivering standard of care. Period 3: Arm-1 intervention study practices add prompts, building upon prior communication skills and performance feedback; Arm-2 comparison study practices continue with standard of care.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||48 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||RCT study design will test the impact of the prompts intervention to reduce missed opportunities and raise HPV vaccine rates.|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Improving HPV Vaccination Delivery in Pediatric Primary Care: The STOP-HPV Trial 3. Comparison of Prompts (in the Presence of Communication Skills and Performance Feedback) and Standard of Care|
|Actual Study Start Date :||August 7, 2018|
|Estimated Primary Completion Date :||July 2021|
|Estimated Study Completion Date :||July 2021|
Arm 1 will receive the STOP-HPV prompts intervention
Behavioral: STOP-HPV prompts intervention
This intervention will be the addition of the prompts intervention (in the presence of communication skills training and continued performance feedback).
No Intervention: Control
Arm 2 will receive standard of care
- Change in the rate of missed vaccination opportunities among all clinicians [ Time Frame: Monthly for Period 3 and also aggregated over the 6 -month period from start date, where start date is site specific and depends on study decision on completion of training and readiness of site to proceed. ]Change in the rate of missed vaccination opportunities from baseline (period 0) through the end of period 3 among all clinicians, with a focus on the contrast between the end of periods 2 and period 3.
- Change in the rate of missed vaccination opportunities among consenting clinicians [ Time Frame: Monthly for Period 3 and also aggregated over the 6 -month period from start date, where start date is site specific and depends on study decision on completion of training and readiness of site to proceed. ]Change in the rate of missed vaccination opportunities from baseline (period 0) through the end of period 3 among consenting clinicians, with a focus on the contrast between the end of period 2 and period 3.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03599583
|United States, Illinois|
|American Academy of Pediatrics|
|Itasca, Illinois, United States, 60143|
|Principal Investigator:||Peter Szilagyi, MD||University of California, Los Angeles|